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PF-06282999

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 31, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment111
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01707082A Study To Test The Safety, Amount And Effects Of PF-06282999 In Healthy Overweight Adults And A Study To Test The Effects Of PF-06282999 On The Amount Of The Approved Drug, Midazolam, In Healthy AdultsPHASE1 COMPLETED 69 — — Oct 1, 2012May 1, 2013Jul 31, 20131 Belgium
NCT01626976A Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult SubjectsPHASE1 COMPLETED 42 — — Jun 1, 2012Mar 1, 2013Mar 13, 20131 Belgium
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax)
Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
Apparent Oral Clearance (CL/F)
Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
Minimum Observed Plasma Trough Concentration (Cmin)
Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Plasma Decay Half-Life (t1/2)
Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Pre-dose,0.5,1,2,3,4,5,6,8,10,12 and 16 hrs post dose Day 1 Period 1 Part B

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) Midazolam

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Pre-dose,0.5,1,2,3,4,5,6,8,10,12 and 16 hrs post dose Day 1 Period 1 Part B

AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). Midazolam

Average Concentration (Cav)
Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Accumulation Ratio
Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Area Under the Curve From Time Zero to 24 hour [AUC24]
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose
Apparent Volume of Distribution (Vz/F)
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Amount of Unchanged Drug Excretion in Urine from Zero to 24 hours (Ae24)
0 to 24 hours post-dose
Percent of Dose Excreted in Urine as Unchanged Drug from Zero to 24 hours (Ae24%)
0 to 24 hours post-dose
Renal Clearance (CLr)
0 to 24 hours post-dose
Oral temperature
0, 1, 2, 4, 8, 12,16, 24, 48 hours post-dose
Secondary Endpoints
Diastolic Blood Pressure
Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
Systolic Blood Pressure
Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
interleukin-6
Days 1 and 14 pre-dose Part A
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Part A Cohort 1EXPERIMENTAL -
Part A Cohort 2EXPERIMENTAL -
Part A Cohort 3EXPERIMENTAL -
Part A Cohort 4EXPERIMENTAL -
Part A Cohort 5EXPERIMENTAL -
Part B Cohort 1EXPERIMENTAL -
Part B Cohort 2EXPERIMENTAL -
Cohort 1EXPERIMENTAL -
Cohort 2EXPERIMENTAL -
Cohort 3EXPERIMENTAL -
Cohort 4EXPERIMENTAL -
Cohort 5EXPERIMENTAL -
Interventions
NameTypeDescription
PF-06282999DRUGTablet, 10 mg, every 8 hours, 14 days
PlaceboDRUGTablet, 0 mg, every 8 hours, 14 days
midazolamDRUGTablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG ...

Countries:Belgium
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